The purpose of this study is to evaluate the correlation between the restoration of the sagittal balance and the improvement of the Quality of Life for patients with adult scoliosis, treated with a polyaxial system (PASS® LP system) during the 2 years after a spinal fusion surgery.
Study Type
OBSERVATIONAL
Enrollment
54
posterior correction and fusion of the thoraco-lumbar or lumbar spine
UC Denver
Denver, Colorado, United States
Santy orthopedic center
Lyon, France
Correlation between correction of SVA and improvement ODI
The primary objective is to evaluate the correlation between: * the correction of the Sagittal Vertical Alignement (SVA), expressed in centimeters - SVA is the distance between C7 plumbline and the posterior of the superior endplate of S1) * the improvement of the Oswestry Disability Index (ODI) is the positive difference of the preoperative score and the postoperative score - expressed in % or a score (/50)
Time frame: preop, 3 months, 6 months, 12 months, 24 months
Correction of the sagittal parameters
Sagittal parameters are evaluated by: \- Cobb angle: Thoracic kyphosis measured from T5 to T12 and between the 2 inflexion points of the curve Lumbar lordosis measured from T12 to S1 and between the 2 inflexion points of the curve * Pelvic Incidence (PI) * Pelvic Tilt (PT) * Sacral Slope (SS) * Proximal junction Cobb angle * T1 spinopelvic inclination (T1-SPI)
Time frame: preop, 24 months
improvement of Quality of life
* The effect that the patient's pathology has on his/her daily life evaluated by the Scoliosis Research Society (SRS-22) questionnaire designed and recommended by the Scoliosis Research Society * Pain reduction for back and leg by the Visual Analogue Scale (VAS) * Patient satisfaction with the results of their operation using a simple questionnaire (Patient Satisfaction Index - PSI) which was designed and recommended by the North American Spine Society (NASS)
Time frame: preop, 3 months, 6 months, 12 months, 24 months
Complications associated with the device
Per and Post-operative device complications: Screw pull-out Loosening, breakage and pseudarthrosis based on x-rays analysis
Time frame: preop, 3 months, 6 months, 12 months, 24 months
Complications associated with the surgery
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Peri-operative data: length of operative time, length of correction time, blood loss … Surgical complications
Time frame: preop, 3 months, 6 months, 12 months, 24 months
Coronal correction
* A pre/post-operative comparison of regular Cobb angles * A pre/post-operative comparison of C7 plumb line (Coronal balance) * A pre/post-operative comparison of Apical Vertebra Translation (AVT)
Time frame: preop, 3 months, 6 months, 12 months, 24 months
Vertebra rotation
* A pre/post-operative comparison of Rotary Vertebra Subluxation (olisthesis) * A pre/post-operative comparison of Apical Vertebra Rotation (AVR) - Nash Moe
Time frame: preop, 24 months
Adjacent levels degeneration
preoperative and post-operative comparison of the disc height of the upper and lower adjacent levels
Time frame: preop, 24 months
Fusion
standing X-Rays observations (osseous formation)
Time frame: preop, 24 months